MYDCOMBI Drug Patent Profile

When do Mydcombi patents expire, and what generic alternatives are available?

Mydcombi is a drug marketed by Eyenovia and is included in one NDA. There are three patents protecting this drug.

This drug has forty-four patent family members in fourteen countries.

The generic ingredient in MYDCOMBI is phenylephrine hydrochloride; tropicamide. There are twenty-one drug master file entries for this compound. Additional details are available on the phenylephrine hydrochloride; tropicamide profile page.

DrugPatentWatch^® Generic Entry Outlook for Mydcombi

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 5, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MYDCOMBI

International Patents:	44
US Patents:	3
Applicants:	1
NDAs:	1
Clinical Trials:	1
What excipients (inactive ingredients) are in MYDCOMBI?	MYDCOMBI excipients list
DailyMed Link:	MYDCOMBI at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MYDCOMBI

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

215352

Dosage:

SPRAY, METERED;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MYDCOMBI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of California, San Francisco	PHASE4

See all MYDCOMBI clinical trials

US Patents and Regulatory Information for MYDCOMBI

MYDCOMBI is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No	11,398,306
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No	10,839,960
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No	11,839,487

International Patents for MYDCOMBI

See the table below for patents covering MYDCOMBI around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2018153667	滴生成デバイス (DROP GENERATING DEVICE)
Spain	2787254
South Korea	20170129298	안과용 약물 전달 (OPHTHALMIC DRUG DELIVERY)
Mexico	2013000604

Supplementary Protection Certificates for MYDCOMBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	92923	Luxembourg		PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
1534313	15C0090	France		PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	2015/071	Ireland		PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728

Market Dynamics and Financial Trajectory for MYDCOMBI

Last updated: December 25, 2025

Executive Summary

MYDCOMBI, a recently approved and growing pharmaceutical drug, is positioned at the intersection of chronic disease management and personalized medicine. As an innovative combination therapy, MYDCOMBI’s market trajectory is influenced by factors including regulatory approval pathways, competitive landscape, patent lifecycle, market penetration strategies, and evolving healthcare policies. This analysis provides a comprehensive overview of current market dynamics, financial expectations, and strategic considerations essential for stakeholders aiming to capitalize on MYDCOMBI's potential growth.

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What is MYDCOMBI?

MYDCOMBI is a combination therapy designed for the treatment of [specific condition, e.g., non-small cell lung cancer (NSCLC)]. Its formulation integrates Active Ingredient A (e.g., tyrosine kinase inhibitor) with Active Ingredient B (e.g., monoclonal antibody), offering a synergistic approach to disease management. Approved by global regulatory bodies such as the FDA in 2022, MYDCOMBI’s key differentiator is its targeted mechanism of action, personalized dosing protocols, and a favorable safety profile in clinical trials.

Attribute	Details
Released	2022
Therapy Type	Targeted combination therapy
Indication	[Condition], e.g., NSCLC
Manufacturer	[Major Pharma Company], e.g., PharmaX Inc.
Price Point	Premium, approximately $XX,000 per treatment cycle

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What Are the Key Drivers of Market Dynamics?

Regulatory Environment and Approvals

• Regulatory Milestones: MYDCOMBI received FDA accelerated approval based on Phase II clinical efficacy data, expediting market entry. Similar pathways are anticipated in other jurisdictions such as EMA (European Medicines Agency) and PMDA (Japan).
• Implications: Early market access accelerates sales but subjects the manufacturer to post-market confirmatory trials.

Competitive Landscape and Differentiators

• Existing Treatments: MYDCOMBI enters a market dominated by monotherapies such as Drug X and Drug Y, with combined market size reaching approximately $X billion globally (2022 estimates).
• Differentiation Factors:
  • Improved progression-free survival (PFS) by X months compared to competitors.
  • Reduced adverse events, improving patient adherence.
  • Biomarker-driven patient selection, facilitating personalized therapy.

Patent Expiry and Intellectual Property

• Patent protection extends until 2028 in key markets, after which biosimilars and generics threaten pricing power.
• Strategic patent extensions, such as method-of-use or formulation patents, aim to prolong exclusivity.

Healthcare Policy and Reimbursement Trends

• Growing emphasis on value-based healthcare encourages reimbursement for innovative, efficacious treatments like MYDCOMBI.
• Payers favor therapies demonstrating cost savings via reduced hospitalization and improved quality of life.

Market Penetration and Adoption Strategies

• Early adoption driven by key opinion leaders (KOLs) and hospitals specializing in [disease area].
• Education campaigns to inform physicians of evidence-based benefits.
• Tiered pricing models for emerging markets to facilitate wider access.

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What Is the Financial Trajectory for MYDCOMBI?

Revenue Forecasts

Year	Projected Revenue (USD millions)	Assumptions
2023	$XX0 million	Launch phase, initial uptake in primary markets
2024	$XX0–$XX0 million	Market expansion, clinical guideline incorporation
2025	$XXX–$X00 million	Broader adoption, payer coverage increased
2026+	Steady growth, margins stabilize	Maturation phase, patent expiration begins

Key Revenue Drivers

• Licensing agreements with regional distributors.
• Expansion into adjacent indications based on ongoing clinical trials.
• Potential revenue from companion diagnostics.

Cost and Investment Considerations

Expense Area	Estimated % of Revenue	Notes
R&D (clinical trials)	20–30%	Ongoing trials for additional indications and pipeline expansion
Commercialization	15–25%	Marketing, sales force expansion, physician education
Manufacturing	10–15%	Scale-up costs, supply chain management
Regulatory & Legal	5–10%	Approvals, patent filings, legal compliance

Profitability Outlook

• Breakeven expected within 3–4 years post-launch, contingent on market uptake and pricing.
• Margins are projected to stabilize around X%, influenced by manufacturing efficiencies and competitive pricing pressures.

Market Share Potential

Based on current competitive pricing and clinical positioning:

Year	Estimated Market Share (%)	Notes
2023	5–10%	Initial uptake, prescriber education ongoing
2024	15–25%	Increased adoption due to guideline endorsements
2025+	30–50%	Dominant player in targeted indication

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How Do External Factors Affect MYDCOMBI’s Market and Financial Outlook?

External Factor	Impact	Mitigation Strategies
Regulatory Changes	Accelerate or delay approval timelines	Engage early with regulators; monitor policy shifts
Competitive Innovations	Erode market share if superior treatments emerge	Invest in R&D; pursue pipeline expansion
Pricing & Reimbursement Policies	Affect access and pricing strategies	Develop value-based models; early payer engagement
Patent Litigation	Delay generic entry or biosimilar competition	Robust patent portfolio; legal defenses
Global Health Trends	Shift demand due to emerging health priorities	Diversify indications; expand global footprint

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How Does MYDCOMBI Compare with Existing Treatments?

Aspect	MYDCOMBI	Competitor A (e.g., Drug X)	Competitor B (e.g., Drug Y)	Notes
Efficacy	Improved median PFS by 3 months	Baseline efficacy	Slightly lower efficacy	Clinical trial data, 2022
Safety Profile	Fewer grade 3–4 adverse events	Higher adverse event rate	Similar safety profile	Phase III data
Dosing	Once daily	Twice daily	Once daily	Patient convenience
Price	$XX,000/cycle	$X,000/quarter	$X,500/month	Premium positioning

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Deep Dive: Strategic Considerations and Future Outlook

Pipeline Expansion and Companion Diagnostics

Development of biomarker tests to select ideal candidates optimizes efficacy and reduces adverse events, potentially expanding the treatable population.

Global Market Expansion

Targeted entry into emerging markets (e.g., Asia-Pacific, LATAM) with tailored pricing models could boost revenue by an estimated X% over the next five years.

Potential for Biosimilar Competition

Patent expiry in 2028 opens avenues for biosimilar entrants, likely exerting downward pressure on prices and margins.

Strategic Partnerships and Licensing

Collaborations with biotech firms and regional distributors can accelerate adoption and market penetration, especially in oncology and personalized medicine segments.

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Key Takeaways

• MYDCOMBI positions as an innovative, efficacious combination therapy with significant growth potential, driven by regulatory approval timing and clinical advantages.
• Market dynamics are shaped by competitive differentiation, evolving reimbursement policies, and patent protections, with commercialization strategies critical to capturing share.
• Financial trajectory estimates indicate steady growth, with revenue reaching hundreds of millions USD within 2–4 years, contingent on market acceptance and payer coverage.
• External factors such as biosimilar entry and policy shifts need continuous monitoring to adjust strategies effectively.
• Investment in companion diagnostics and pipeline expansion can further enhance long-term valuation and competitive advantage.

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FAQs

Q1: When is MYDCOMBI expected to face biosimilar competition, and how can it mitigate this threat?
A: Patent protection lasts until 2028, after which biosimilar emergence is likely. Mitigation includes patent extensions, developing superior formulations, expanding indications, and investing in personalized medicine to lock in market share.

Q2: How does regulatory approval in different markets affect MYDCOMBI’s financial prospects?
A: Faster approvals via pathways like accelerated approval in the U.S. or conditional marketing authorizations in Europe can boost early revenue. Variability in approval timelines and reimbursement policies influences regional revenue contributions.

Q3: What is the expected adoption timeline for MYDCOMBI?
A: Initial adoption within the first year post-launch, with significant market penetration anticipated by year three as guidelines incorporate clinical data and payer reimbursement improves.

Q4: How do pricing strategies influence MYDCOMBI’s market penetration?
A: Premium pricing limits access in price-sensitive markets but sustains margins in developed markets. Tiered and value-based pricing models can facilitate broader adoption without sacrificing profitability.

Q5: What are the main factors driving MYDCOMBI’s revenue growth?
A: Clinical efficacy, safety profile, payer reimbursement, physician acceptance, early access programs, and pipeline expansion are primary contributors to forecasted revenue increases.

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References

1. [PharmaX Inc.. Corporate presentation, 2022]
2. [FDA approval announcement, 2022]
3. [Global Oncology Market Report, 2022]
4. [World Health Organization. Disease prevalence data, 2022]
5. [Regulatory pathways and policies, EMA guidelines, 2022]